Cook Inc. Recalls TFE Coated Curved Newton LLT Due to Labeling Error
Cook Inc. is recalling 3,364 units of TFE Coated Curved Newton LLT because the label fails to state that the product is heparin-coated.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states no illnesses or injuries have been reported, and the hazard is a labeling error rather than a direct physical defect.
Plain-English summary
Cook Inc. is recalling 3,364 units of TFE Coated Curved Newton LLT. The recall was initiated because the product label does not state that the product is heparin-coated.
The affected units were distributed nationally. The specific catalog number is TSCFNB-35-180-SPENCERMOD-BH. Affected lots include 3741882 through 6142463, F3884311 through F4903643, and NS5044201 through NS5963180.
This is a Class II recall. The FDA has not reported any illnesses or injuries associated with this labeling error. Users should check their inventory for the affected lot numbers and contact the manufacturer for further instructions.
The recalled product
- Product
- TFE Coated Curved Newton LLT
- Manufacturer
- Cook Inc.
- Hazard
- Affected units
- 3,364
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 20 recalled by Cook Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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